Reinvigorating The Coronary Stent Market: Can Bioresorbable Scaffolds Do The Job?

Article preview from Medtech Insight - May, 2013

Bioresorbable coronary scaffolds could transform the coronary stenting market once they become widely available. But although there are more than a dozen companies developing these promising devices, there are still a number of unanswered questions – chief among them, how effectively they will compete against existing and upcoming next-generation durable stents, and how much of a price premium bioresorbable devices will be able to command.

Reinvigorating The Coronary Stent Market: Can Bioresorbable Scaffolds Do The Job?

Article preview from Medtech Insight - May, 2013

With percutaneous coronary intervention (PCI) procedure volumes continuing to decline in the US and Europe, and coronary drug-eluting stents (DES) becoming commoditized as a result of increased competition and pricing pressures, some may wonder when (and where) the DES market, currently valued at about $1.3 billion in the US and about $4 billion worldwide, will bottom out. However, perhaps the more significant question is whether or not there is a next-generation technology in the pipeline with the ability to re-energize this space and return it to the growth track seen in years past. As is often the case, the answer is not a simple one. Although DES market leaders are spending millions developing next-generation products, it remains to be seen just how successful they will be and how much of a price premium they will be able to command.

Many of these new devices have improved stent platforms, including thinner struts and thinner, resorbable polymer coatings, designed to improve stent biocompatibility and performance, particularly with respect to late stent thrombosis and the goal of reducing the recommended duration of dual antiplatelet therapy (DAPT) after DES implantation. For example, one next-generation DES that has attracted a lot of positive attention lately is the everolimus-eluting Synergy stent with resorbable polymer-drug coating, under development by Boston Scientific Corp. Built on a platinum-chromium stent platform, Synergy has the thinnest struts (0.029 inch), thinnest polymer coating (4 microns, on the abluminal side only), and fastest polymer dissolution time (90% is gone within 90 days) of any similar DES available or in development at the moment, according to Dean J. Kereiakes, MD, medical director, The Christ Hospital Heart and Vascular Center and The Lindner Research Center, Cincinnati, OH, who spoke recently with Medtech Insight. Kereiakes, who is the national principal investigator (PI) for Boston Scientific’s EVOLVE II trial, the approximately 2,000-patient, pivotal, Investigational Device Exemption (IDE)-approved noninferiority study comparing the Synergy device with Boston Scientific’s Promus Element durable polymer DES, says Synergy is extremely flexible, conformable, and fracture resistant, and is designed to outperform other similar devices by a “factor of at least two to three.” It will be a “workhorse” device, he says. The reasoning behind the ultra-thin polymer coating on Synergy is that more rapid disappearance of the polymer will accelerate vessel healing to some extent. “And Synergy’s polymer is the “fastest dissolving yet,” Kereiakes points out.

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